Lois Rossi Director, Registration Division

Office of Pesticide Programs U.S. Environmental Protection Agency Washington, DC March 19, 2013

# Overview

 Purposes for EPA consideration of product performance data requirements, testing and standards.

 Current product performance data requirements/practices

 Need for product performance standards

 EPA Product Performance Guidelines

 Global harmonization efforts.

# Purposes

 

### Increasing transparency

 

### Providing clear expectations for data development to support product registration

 

### Outlining consistent testing/evaluation that should vary little between registrants, products, or lab choice

 

### Ensuring more consistent efficacy of EPA registered products4 

## Product Specific Data Requirements for Insecticide and Repellent Product Registrations

 

### Product Chemistry

 

### Acute Toxicity

-- determines precautionary labeling

 

### Product Performance

– substantiates specific label claims, addition of pests, and related use patterns

# Product Performance Data

 

### Document how well the product performs its intended function (killing, knockdown, repelling, etc.) against an invertebrate pest(s).

# FIFRA

 

### FIFRA directs EPA to specify the kinds of data that applicants and registrants must submit to EPA to support regulatory determinations under FIFRA.

 

### The data that EPA is considering for codification are consistent with the agency’s current practices for the product performance data needed to register a pesticide product that bears a pesticidal claim against one or more pests.

# Currently

- When are Product Performance Data Required?

 Submission of data is typically waived; however, registrants are required to have data on record for all pests listed on the label.

 When product failures are reported to EPA by the registrant.

 When a product makes claims to kill, knockdown, control, repel or attract pests that are of significant public health importance, wood destroying, and/or considered an invasive species. Submission of these data is suppose to be case - by

- case but has become routine for product registration.

# Current Product Performance Data Needs

 For public health pests of significant public health importance including mosquitoes, ticks, cockroaches, bed bugs, etc.

 For pests of economic importance including wood destroying insects and invasive species.

 Agricultural pest data requirement waived

# Options for Fulfilling Product Performance Data Requirements

 

### Cite existing data

- usually from studies conducted with a similar product and use pattern.

 

### Submit new product specific studies.

# Product Performance Standards

 

### Currently, performance standards are not stated in the regulations. Instead, they typically appear in EPA guidelines.

 

### EPA is considering codifying product performance standards . Guidelines would be revised to remove all standards.

 

### The Technical Support Document includes a discussion of a 95% level of performance as the typical standard.

# Product Performance Standards

 A few other standards are also discussed

- such as a 100% level of performance for soil applied termiticides.

 A two

- hour Complete Protection Time (CPT) is considered for skin applied repellents.

# EPA Product Performance Testing Guidelines

 

### Provide guidance on testing methods, designs, data reporting.

 

### 810 series guidelines

 

### 810.30

- 36 last revised in 1998

 

### EPA is interested in recommendations from this Scientific Advisory Panel on revisions to the above guidelines

# EPA Product Performance Testing Guidelines

 

### More recent guidelines include:

 810.3700

– Skin Applied Insect Repellent products

– completed in 2010.

 810.3800

- Termite Bait products

– completed in 2004.

 Draft 810.3900

– Bed bug products

– 2012
– in process EPA does not want to revisit the above guidelines in this meeting because the agency considered the recommendations from previous Scientific Advisory Panels in the finalization of these EPA guidelines.

# EPA Product Performance Guidelines

 

### New Guidelines

 Spatial repellents

 Fumigants

 Insecticide impregnated fabrics

 Attractants

 

### EPA looks forward to recommendations from the panel regarding these guidelines and other suggestions for additional guidelines that might be needed.

# Conclusions

 

### Advice from the Scientific Advisory Panel is a vital part of our deliberations on the types of product performance data that might be needed for EPA to evaluate the efficacy of pesticide products.

 

### We welcome the SAP’s input and public comments on the scientific issues associated with product performance data and are looking forward to a productive meeting.